Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Rituximab Pateinets With Aggresive NHL
Overview[ - collapse ][ - ]
| Purpose | We now propose to investigate the combination of CHOP-Rituxan plus PEG-Filgrastim (PEG-filgrastim) and GM-CSF. PEG-Filgrastim would be given in order to allow us to administer the chemotherapy courses every 2 weeks with the practical advantage of requiring only one dose of PEG-filgrastim instead of daily doses of G-CSF. |
|---|---|
| Condition | Lymphoma Non Hodgkin's Lymphoma |
| Intervention | Drug: Cyclophosphamide, Doxorubicin, Vincristine and Prednisone |
| Phase | Phase 1/Phase 2 |
| Sponsor | Fernando Cabanillas |
| Responsible Party | Auxilio Mutuo Cancer Center |
| ClinicalTrials.gov Identifier | NCT01527422 |
| First Received | February 3, 2012 |
| Last Updated | February 3, 2012 |
| Last verified | February 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 3, 2012 |
|---|---|
| Last Updated Date | February 3, 2012 |
| Start Date | January 2006 |
| Estimated Primary Completion Date | March 2011 |
| Current Primary Outcome Measures | Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF combined with CHOP-R [Time Frame: up to 3 years] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Rituximab Pateinets With Aggresive NHL |
|---|---|
| Official Title | Protocol CCAM 05-02 " Phase I-II Study of Dose Dense of PEG Filgrastim and GM-CSF as Support for Dose Desnse CHOP-R Front Line Therapy for Aggressive Non Hodgkin's Lymphoma" |
| Brief Summary | We now propose to investigate the combination of CHOP-Rituxan plus PEG-Filgrastim (PEG-filgrastim) and GM-CSF. PEG-Filgrastim would be given in order to allow us to administer the chemotherapy courses every 2 weeks with the practical advantage of requiring only one dose of PEG-filgrastim instead of daily doses of G-CSF. |
| Detailed Description | 1.1 Primary Objective: 1. To identify the ideal dose of the combination of CHOP-R with PEG-Filgrastim (Neulasta) using first a fixed dose of Neulasta and an escalating dose of GM-CSF (Leukine) up to 250 mcg. When that dose is reached, if possible, the dose of Neulasta will be increased stepwise. CHOP-R will be delivered every 14 days at a fixed standard dose with dose adjustments of PEG-Filgrastim and GM-CSF upwards and downwards according to nadir or zenith blood counts. 1.2 Secondary Objective: 2. To generate preliminary pilot data as to the effectiveness of the regimen in inducing very early remissions as measured by the CT-PET scan technique. |
| Study Type | Interventional |
| Study Phase | Phase 1/Phase 2 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Cyclophosphamide, Doxorubicin, Vincristine and Prednisone Rituximab will be administered on day 1 of courses 1-6 at 375 mg/m2 concurrently with CHOP-R.All patients will receive antiemetics priorchemotherapy.Courses will be repeated every 14 days.If blood counts don't allow re-treatment on day 14 the counts will be repeated at least twice per week until recovery allows re-treatment.The aim is to achieve a dose that will be as close as possible to 250 mcg and that will result in grade 0 or grade 1A or 1B toxicity at the most. The dose of PEG-Filgrastim will initially be fixed at 3 mg until dose level +3 is reached (which includes 250 mcg Leukine) at which time the dose of Neulasta will be escalated if necessary. All patients will receive Neulasta as a subcutaneous injection on the day 3. Other Names:
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| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 60 |
| Estimated Completion Date | March 2011 |
| Estimated Primary Completion Date | November 2010 |
| Eligibility Criteria | Inclusion Criteria: - Patients with previously untreated aggressive non-Hodgkin's Lymphoma. Aggressive histologies include follicular large cell, diffuse large cell, peripheral T cell, transformed lymphomas, Lymphoblastic lymphomas, Burkitt and Burkitt like lymphomas. - Must have measurable or evaluable disease. - Stage I-IV patients are eligible - Patients must be 18 years or older. - No evidence of grade 3 or more neurosensory or neuromotor dysfunction (see appendix- toxicity criteria) - Written Consent Exclusion Criteria: - HIV positive patients and those with Hepatitis B or C will be excluded from this protocol. - Patients with inadequate bone marrow and organ function as defined below: - Neutrophils <1,000/l - Platelets <100,000/l - Billirubin >2 - Creatinine >2.0 or estimated CrCl <30 cc/min - CNS involvement by Lymphoma. - Uncontrolled intercurrent disease including arrhythmias, angina pectoris, Class III-IV Congestive heart failure (CHF symptoms on less than ordinary exertion or at rest) or active infection. - Active infection or fever > 38.2 degrees C unless due to lymphoma. - Subject is not using adequate contraceptive precautions. - Pregnancy or breast feeding |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Puerto Rico |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01527422 |
|---|---|
| Other Study ID Numbers | NCT01297478 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Auxilio Mutuo Cancer Center |
| Study Sponsor | Fernando Cabanillas |
| Collaborators | Genzyme, a Sanofi Company |
| Investigators | Principal Investigator: Fernando Cabanillas, MD AuxilioPrincipal Investigator: Fernando Cabanillas, MD Auxilio Mutuo Cancer Center/Hospital Auxilio Mutuo |
| Verification Date | February 2012 |
Locations[ + expand ][ + ]
| Hospital Auxilio Mutuo Cancer Center | San Juan, Puerto Rico, 00919 |
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